Real‐World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study
Authors' conclusion
These findings confirm the drug's long-term clinical benefit and safety profile in a routine-care setting.
Study context
- Population
- Adults with monogenic or syndromic obesity on setmelanotide under pre-marketing early-access authorization, started in routine care 2022–2024 or continued after the RM-493–022 trialmean follow-up 14.4 months
- Participants
- 17 adults
- Exposure
- Bardet-Biedl syndrome (BBS) vs leptin receptor (LEPR) vs pro-opiomelanocortin (POMC)
- BBSn = 11
- LEPRn = 4
- POMCn = 2
- Outcome
- Weight reduction from highest pre-treatment weight
- Follow-up
- Within the first year
Methodological detailsmonocentric, ongoing, real-world
- Monocentric
- Ongoing
- Real-world
Main finding
As reported in the abstract
Weight reduction from highest pre-treatment weight
20%
Observational data: associations, not effects.
Further findings
Eating behavior
- Hunger reduction
- −62%
- Food craving reduction
- −41%
- Significant reduction in external eating (DEBQ)
Safety
- Safety profile consistent with phase 3 trial data, without any new safety signals
Original publication
Real‐World Efficacy and Safety of Setmelanotide in Adults With Monogenic or Syndromic Obesity: A Prospective Cohort Study. Obesity (Silver Spring). Published 2 September 2025. doi:10.
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